510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LJKClass II

Antisera, If, Toxoplasma Gondii

21 CFR 866.3780 / Microbiology
FDA source (opens on fda.gov)

LJK is the FDA product code for Antisera, If, Toxoplasma Gondii, a class II device type, regulated under 21 CFR 866.3780. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LJK
Device name
Antisera, If, Toxoplasma Gondii
Regulation
21 CFR 866.3780
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
0

Clearances, product code LJK

By decision year
6 clearances under product code LJK with a decision year between 1982 and 1997, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LJK by decision year
YearClearances
19821
19831
19861
19871
19911
19971

Applicants with the most clearances

Product code LJK
Applicants holding the most 510(k) clearances under product code LJK
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic1
Bionetic Laboratory Products1
Boston Biomedica, Inc.1
Immulok, Inc.1
Microbiological Research Corp.1
Widran Urological Group, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code